Eight months af­ter fil­ing for IPO, the mak­er of Chi­na's Ebo­la vac­cine joins HKEX with $161M raise

The Hong Kong stock ex­change is wel­com­ing its first pre-rev­enue vac­cine mak­er on board.

Tian­jin-based CanSi­no scored $160.5 mil­lion in an IPO by sell­ing 57.2 mil­lion shares at $2.8, or HK$22, the top of the range. Around 40% of the cap­i­tal came from lo­cal in­vestors and the rest went to in­ter­na­tion­al com­mu­ni­ty, both of which over­sub­scribed. The pub­lic de­but donned a val­u­a­tion of $611.6 mil­lion, ac­cord­ing to Bio­Cen­tu­ry.

Xue­feng Yu

Known do­mes­ti­cal­ly for its ap­proved Ebo­la vac­cine, CanSi­no’s sto­ry traces back to a bar­beque in Toron­to a decade ago, where the four Chi­nese-Cana­di­an founders — se­nior ex­ecs at Sanofi Pas­teur, As­traZeneca and Wyeth at the time — de­cid­ed they want­ed to do more than just lament­ing the glar­ing hole in Chi­na’s vac­cine field.

Xue­feng Yu took up the chair­man and CEO role, Tao Zhu be­came the CSO, while He­len Hui­hua Mao and Dongxu Qiu both helped as deputy gen­er­al man­agers. To­geth­er, they built up a pipeline of 15 vac­cine can­di­dates across 12 dis­ease ar­eas, en­tic­ing top-notch in­vestors Lil­ly Asia Ven­tures and Qim­ing Ven­tures as well as the state-owned Fu­ture In­dus­try De­vel­op­ment Fund.

LAV dou­bled down as one of the cor­ner­stone in­vestors of the IPO along­side Or­biMed and Tsinlen Zhuo Rui In­vest­ment (an af­fil­i­ate of the Tian­jin gov­ern­ment), which to­geth­er pur­chased about 16 mil­lion shares.

Tao Zhu

CanSi­no pledged to spend the vast ma­jor­i­ty of the raise to R&D and com­mer­cial­iza­tion ef­forts around its clin­i­cal prod­ucts. That ranges from two Phase III meningo­coc­cal pro­grams and two Phase I DTP vac­cines to an ear­ly-stage tu­ber­cu­lo­sis boost­er and a next-gen, pro­tein-based pneu­mo­coc­cal vac­cine.

The plan, they wrote in their ap­pli­ca­tion last Ju­ly, is to have 100 staffers ded­i­cat­ed to sell­ing the vac­cines to lo­cal cen­ters for dis­ease con­trol, ini­tial­ly in 30 eco­nom­i­cal­ly-de­vel­oped cities and grad­u­al­ly ex­pand­ing to oth­er lo­ca­tions.

Mean­while, half a dozen pre­clin­i­cal as­sets — cov­er­ing com­mon sus­pects like shin­gles and Zi­ka — will split 10% of the IPO mon­ey.

CanSi­no will be­gin trad­ing on Thurs­day, join­ing the HKEX close to the first an­niver­sary of the new list­ing rules that opened it up to pre-rev­enue biotechs. Im­muno-on­col­o­gy play­er CStone Phar­ma is the on­ly oth­er com­pa­ny so far in biotech class of 2019, hav­ing bagged $285 mil­lion in Feb­ru­ary.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Vivek Ramaswamy (Jeff Rumans/JPM 2020)

Urovan­t's lead drug dis­ap­points in mid-stage study as first big FDA de­ci­sion looms

Just as Urovant gets ready for its first big FDA decision on vibegron, the drug has flopped in what would’ve been a follow-on indication.

In a Phase IIa trial involving women with abdominal pain due to irritable bowel syndrome, vibegron failed to meet the bar on improving “average worst abdominal pain” over 12 weeks, compared to placebo, among IBS-D patients.

There were actually slightly more responders in the placebo group than in the drug arm, with only 40.9% of those randomized to vigebron achieving at least a 30% decrease in “worst abdominal pain” in the past 24 hours. The trial enrolled 222 women but only 189 completed the study.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.